Traditional market mechanisms for the development of new diagnostics and vaccines are failing with regard to pubic health generally and response to bioterrorism in particular, where the principal market is likely to be federal and state governments. National orphan vaccine centers, perhaps created as government-owned, contractor-operated (GOCO) facilities, are needed to help bring vaccines for otherwise rare diseases to the stages of mass manufacture. Such centers could help coordinate extramural R&D activities in the public and private sectors as well as perform critical research. In particular, national orphan vaccine centers could coordinate the clinical trials and studies with animals on which licensing would be based, and could serve as conduits for production at industrial facilities (including development of surge vaccine-manufacturing capacity and the training of personnel to produce vaccines that meet FDA standards). Such collaboration would require the establishment of new relationships between the public and private sectors.

For development of broad-spectrum antibiotics and antivirals, federal funding should encourage the large pharmaceutical and biotechnology companies to enter the field with the expectation that at least some drugs developed for bioterrorist threats will have dual use—that is, they may be applicable to common infectious diseases as well. Such encouragement for undertaking R&D on new drugs against bioterrorism agents could take the form of streamlined grant mechanisms, financial incentives, and regulatory changes.

Regulatory Reform

Maintaining public confidence in vaccines, and in medical products in general, is critical to assuring overall confidence in the nation’s public health programs. But bioterrorism is a moving target, not a single disease of predictable epidemiology, and all potential product uses may not be anticipated. This complicates many decisions about product use.

Current biodefense-related activities at the FDA include meeting with sponsors and sister agencies to encourage interest in developing safe and effective new products, performing research that ultimately facilitates the development of these products, and intensively interacting with product sponsors to expedite availability.

Other steps that the FDA has employed in an attempt to safely speed up the licensure process include the following:

  • Emergency use under investigational new drug (IND) status allows rapid access to products that have not yet completed requirements for licensure. While IND status makes available potentially lifesaving items, a disadvantage of emergency use under this rule is that the product is not licensed, which not only reflects the true scientific limitations of the data but also raises important issues about public perception.



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